Bionpharma Recalls Doxylamine Succinate Tablets Due to Foreign Material Presence
Bionpharma Inc. is recalling Doxylamine Succinate and Pyridoxine HCl tablets because foreign tablets or capsules were found in the product.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences, and no specific injuries or illnesses are reported in the source text.
Plain-English summary
Bionpharma Inc. is recalling 14,232 bottles of Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets (10 mg/10 mg). The recall is due to the presence of foreign tablets or capsules in the product.
The affected product is Lot # DMA25006 with an expiration date of 11/30/2028. The 100-count bottles were distributed nationwide in the United States.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on next steps.
The recalled product
- Product
- DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE)
- Brand
- DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
- Manufacturer
- Bionpharma Inc.
- Category
- Drug — Prescription Drug
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # DMA25006
- Exp Date: 11/30/2028.
Distribution
Distributed nationwide across the United States.
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